| CTRI Number |
CTRI/2022/06/043519 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
SNUHYADI VARTI IN THE MANAGEMENT OF BHAGANDAR (FISTULA-IN-ANO) |
|
Scientific Title of Study
|
CLINICAL COMPARATIVE STUDY OF SNUHYADI VARTI AND ASHWATTHA KSHARA SUTRA IN THE MANAGEMENT OF BHAGANDAR W.S.R TO FISTULA-IN-ANO |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Diwakar |
| Designation |
PG Scholar |
| Affiliation |
Sampurnanand Sanskrit vishwavidhalaya |
| Address |
Department of Shalya Tantra, Govt. PG Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9557585217 |
| Fax |
|
| Email |
nehadiwakar95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrigank Shekhar |
| Designation |
Assistant Professor |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Department of Shalya Tantra, Govt. PG Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453788863 |
| Fax |
|
| Email |
drmrigank.bhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Diwakar |
| Designation |
PG Scholar |
| Affiliation |
Sampuranand sanskrit university, varanasi |
| Address |
Department of Shalya Tantra, Govt. PG Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9557585217 |
| Fax |
|
| Email |
nehadiwakar95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. PG Ayurved College and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Govt PG Ayurved College and Hospital Varanasi |
| Address |
Department of Shalya Tantra, Govt. PG Ayurved College and Hospital, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Diwakar |
Govt. PG Ayurved College and Hospital, Varanasi |
Department of Shalya Tantra, Govt. PG Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH |
9557585217
nehadiwakar95@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt. PG Ayurved College and Hospital, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: bhagandar , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | surgical intervention | (Procedure Reference: Bhaishjya Ratnawali bhagandar chikitsa adhyaay 51/3, Procedure details: Snuhyadi varti application with internal fistulous opening closure 4-6 times for 1-2 months.)
| | 2 | Comparator Arm | Procedure | - | surgical procedure | (Procedure Reference: , Procedure details: Ashwattha kshara sutra ligation 4-6 times for 1-2 months.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from Bhagandar will be taken.
2.Patient of Bhagandar those medically fit for surgery irrespective of either sex, occupation and religion will be included randomly.
3.Age of patient 20-60 years will be included.
4.Simple anal fistula with palpable induration
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Hypertension
2. Uncontrolled Diabetes mellitus
3. Tuberculosis
4. Osteomyelitis
5. Chronic or Acute Ulcerative colitis
6. Crohn’s disease
7. Any malignancy
8. Venereal disease, HIV, HCV and HBsAg positive cases
9. Pregnancy
10. Fistula other than ano-rectal region
11. Age less than 20 years and more than 60 years
12. Rectal prolapsed
13. Complex fistula with multiple opening
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To overcome the symptoms of pus discharge, pain, induration and foul smell |
45-60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
less hospital stay
painfree therapy
reduce post-operative complication
improve routine activity |
3-4 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2022 |
| Date of Study Completion (India) |
30/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Interventional Study
Patient suffering from fistula-in-ano will be selected from OPD and IPD of Govt. PG Ayurved College and Hospital, Varanasi
total patient = 60
Treatment Plan- GROUP A: (30 patients) - will be treated by internal fistulous opening closure and application of Snuhyaadi Varti in fistulous track. (Partial fistulotomy if needed.) GROUP B: (30 patients) - will be treated by application of Ashwattha Kshara Sutra in fistulous track. (Partial fistulotomy if needed) Follow Up = 15 days
|